DropSthetic (Drops) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

S01HA04 (Proxymetacaine)

Active Substance

Proxymetacaine (Rec.INN registered by WHO)

Dosage Form

DropSthetic

Eye drops 5 mg/1 ml: bottle or dropper bottle 15 ml

Dosage Form, Packaging, and Composition

Eye drops in the form of a clear solution from colorless to slightly yellowish or slightly yellowish-brownish in color.

Excipients: benzalkonium chloride, glycerol, concentrated hydrochloric acid and/or sodium hydroxide (for pH adjustment), water for injections.

15 ml – polyethylene bottles (1) with a dropper – cardboard boxes.
15 ml – polyethylene dropper bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Local anesthetic for use in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology; local anesthetics

Pharmacological Action

A local anesthetic agent for use in ophthalmic practice. The effect begins within 30 seconds after instillation and lasts for 15 minutes with a single instillation.

Proxymetacaine inhibits the permeability of cell membranes to sodium ions, which prevents the generation of impulses in nerve endings and the conduction of impulses along nerve fibers.

Pharmacokinetics

After instillation into the conjunctival sac, it is rapidly absorbed and hydrolyzed by plasma esterases. It is excreted by the kidneys as inactive breakdown products.

Indications

In ophthalmology for performing short-term diagnostic and therapeutic procedures requiring rapid and short-term anesthesia: including tonometry, tonoscopy, removal of foreign bodies.

ICD codes

Dosage Regimen

Administer by instillation into the conjunctival sac. The regimen is set individually based on the specific diagnostic or therapeutic procedure.

For tonometry, instill one to two drops immediately before the measurement.

For removal of superficial foreign bodies or sutures, instill one to two drops prior to the procedure.

For more extensive surgical procedures, one to two drops may be instilled every five to ten minutes for two to three doses as required.

Avoid prolonged use or frequent repeated applications. Repeated sequential application leads to a decreased duration of anesthetic action, necessitating additional instillations, which increases the risk of severe corneal complications.

When used concomitantly with other ophthalmic medications, maintain an interval of at least five minutes between instillations. Apply eye ointments last.

Do not use the solution if it becomes discolored or contains particulate matter.

Strictly adhere to aseptic technique during administration to prevent contamination of the dropper tip and solution.

Adverse Reactions

Local reactions: frequent – eye itching, eye irritation, conjunctival hyperemia; infrequent – ulcerative keratitis, keratitis, corneal infiltrates, corneal edema, iritis, descemetitis, severe immediate allergic reactions from the cornea, characterized by diffuse epithelial keratitis with detachment of necrotized epithelium and diffuse stromal edema; rare – development of filamentous keratitis accompanied by diffuse stromal edema; frequency unknown – vision loss, corneal perforation, corneal infection, corneal erosion, corneal clouding, blurred vision, photophobia, mydriasis, eye pain, eye swelling, eye discomfort sensation, eye hyperemia, increased lacrimation.

Systemic reactions rare – hypersensitivity reactions, systemic toxicity manifested by CNS excitation followed by its depression; frequency unknown – fainting.

Contraindications

Hypersensitivity to proxymetacaine.

Use with caution in patients with allergic reactions, epilepsy, heart disease, hyperthyroidism, and respiratory disorders; in patients with myasthenia gravis, in patients with low plasma acetylcholinesterase levels, as well as in patients undergoing treatment with cholinesterase inhibitors (as they are at greater risk of systemic adverse reactions), in children under 18 years of age.

Use in Pregnancy and Lactation

Use during pregnancy is not recommended. If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

Should be used with caution in children and adolescents under 18 years of age (due to the lack of sufficient experience with use in this category of patients).

Special Precautions

Repeated sequential application of proxymetacaine causes a decrease in the duration of its action, which requires additional instillation. However, in this case, there is a high risk of developing infection, clouding, or perforation of the cornea.

If necessary, Proxymetacaine can be used in combination with other ophthalmic drugs. In this case, the interval between their use should be at least 5 minutes. Eye ointments should be applied last.

Influence on the ability to drive vehicles and mechanisms

During the use of proxymetacaine, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.